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Model Number PRT-01185-002 |
Device Problems
Connection Problem (2900); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H6: the device was not returned to ventec for evaluation.The device was further evaluated by the authorized service provider (asp) where the reported issues of it displaying a patient circuit disconnect alarm, measuring lower peep (positive end expiratory pressure) than set, having low exhaled tidal volume (vte) levels as well as low inspiratory pressure were all confirmed.The asp replaced the internal flow transducer (ift) to resolve the reported issues.Proper device operation was then observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift.H3 other text : serviced by asp.
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Event Description
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An authorized third party service provider (asp) contacted ventec to report that the ventilator measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.In addition, the device's inspiratory pressure was low and it displayed a patient circuit disconnect alarm.There were no reports of patient involvement associated with the reported event.
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Search Alerts/Recalls
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